Clinical Database Programmer

🕒 vor 5 Tagen

🌐 Vereinigte Staaten, Brasilien, +1 weitere Länder – Remote

🇺🇸 Vereinigte Staaten – Remote 🇧🇷 Brasilien – Remote 🇦🇷 Argentinien – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

🖥 Softwareentwickler

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EDETEK Inc.

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 2009

💊 Pharmazie

🧬 Biotechnologie

☁️ SaaS

Pharmaceuticals • Biotechnology • SaaS

Die EDETEK Inc. ist ein Unternehmen für klinische Entwicklungsinformatik, das ein cloud-natives R&D Cloud Ökosystem und eine integrierte eClinical-Plattform zur Unterstützung von klinischen Studien und regulatorischen Einreichungen bereitstellt. Ihr Produktportfolio umfasst CONFORM™ Orchestrierungs- und Kollaborationstools, eine eClinical Suite (CTMS, EDC, ePRO/eCOA, RTSM), Datenintegrations- und Metadaten-Hubs, einen Clinical Data Lake sowie statistische Analyse- und einreichungsbereite Umgebungen. EDETEK bietet außerdem Dienstleistungen an – Biostatistik und Programmierung, klinisches Datenmanagement, Entwicklung klinischer Studien, medizinisches Schreiben und eClinical Operations – und richtet sich an Pharma-, Biotechnologie- und Medizingerätesponsoren. Das Unternehmen legt Wert auf Interoperabilität, Datenqualität und KI-gestützte Fähigkeiten, um die Durchführung von Studien und regulatorische Einreichungen weltweit zu beschleunigen.

Beschreibung

• The eClinical / Medidata Database Programmer is responsible for building, configuring, testing, and maintaining clinical study databases and related eClinical system components. • Support clinical trial study startup, database build, edit check programming, system configuration, user acceptance testing, issue resolution, and production support. • Build and configure study databases in Medidata Rave or other eClinical platforms based on protocol, CRF specifications, data management plan, and sponsor requirements. • Configure electronic case report forms, visit schedules, fields, folders, matrices, forms, dynamics, derivations, and edit checks. • Support setup of study-specific workflows, roles, permissions, user groups, sites, countries, and access controls. • Configure standard and study-specific data entry rules, validation checks, and system behavior. • Support setup or configuration of coding dictionaries, external data transfers, lab data, eCOA/ePRO, RTSM/IWRS, or other integrated systems. • Develop and maintain edit checks, derivations, dynamics, and custom functions according to approved specifications. • Review edit check specifications and provide technical input to ensure checks are clear, accurate, and programmable. • Perform unit testing and support independent validation of database configuration and edit checks. • Resolve database build defects identified during testing, UAT, or production use. • Maintain documentation of build changes, testing evidence, and issue resolution. • Review clinical protocol and CRF design requirements. • Support development or review of CRF specifications, edit check specifications, and data validation specifications. • Identify inconsistencies among protocol requirements, CRFs, edit checks, and database configuration. • Collaborate with data managers, clinical teams, programmers, vendors, and sponsors to clarify requirements. • Support user acceptance testing, including test script development, test execution, defect tracking, and resolution. • Assist study teams with database-related questions during study startup, conduct, and closeout. • Troubleshoot production database issues and implement approved changes through change control. • Support mid-study updates, amendments, migration activities, and post-production database changes. • Ensure all database changes are properly documented, tested, reviewed, and approved. • Follow applicable SOPs, work instructions, validation procedures, and study-specific requirements. • Ensure database build activities comply with GCP, 21 CFR Part 11, audit trail expectations, and applicable regulatory requirements. • Maintain clear documentation for system configuration, testing, validation, and change control. • Support audits, inspections, and sponsor requests related to database build and eClinical system configuration.

🎯 Anforderungen

• Bachelor’s degree in life sciences, computer science, information systems, statistics, data management, or a related field. • Hands-on experience building clinical study databases in Medidata Rave, Rave EDC, or similar eClinical systems. • Experience with CRF design, edit check programming, database testing, and UAT support. • Good understanding of clinical trial processes and clinical data management activities. • Familiarity with GCP, 21 CFR Part 11, and computerized system validation principles. • Strong attention to detail and ability to follow specifications and controlled processes. • Good communication skills and ability to work with data management, clinical operations, programming, QA, vendors, and sponsor teams. • Medidata Rave database build experience, including Architect, Designer, Coder, Custom Functions, Amendment Manager, or related modules (Preferred). • Experience with multiple therapeutic areas and global clinical trials (Preferred). • Experience supporting Phase I to Phase III studies (Preferred). • Experience with external data integration, lab data, ePRO/eCOA, RTSM/IWRS, safety systems, or central monitoring systems (Preferred). • Experience with CDISC SDTM concepts or downstream data mapping requirements (Preferred). • Experience supporting audits, database validation, or study migration activities (Preferred). • Experience working in a CRO, pharmaceutical, biotech, or clinical technology environment (Preferred).

🏖️ Vorteile

• Choice of comprehensive Medical, Vision and Dental Insurance plans • Paid vacation time and sick days • Corporate holidays annually • Participation in the 401K Plan • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc. • Health Advocate and Employee Assistance Program